Class II
Ongoing
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
This recall is currently active, issued November 23, 2022. It was issued by Icu Medical Inc.
- Company
- Icu Medical Inc
- Recall Initiated
- November 9, 2022
- Posted
- November 23, 2022
- Recall Number
- D-0062-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 137,120 bags
- Firm Location
- Lake Forest, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Distribution
Nationwide in the USA
Lot / Code Info
Lot: 5829936, Exp. MAR 31 2024
More recalls by Icu Medical Inc
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Jan 16, 2026
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Jan 16, 2026
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Jan 16, 2026
Plum Duo Infusion System, List Number 40002-04-01
Jan 15, 2026
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